Ministero della Salute
Following the State-Regions Agreement of May 10, 2023 - Rep. No. 101/CSR, the Decree of the Minister of Health adopting the new National Health Technology Assessment Program 2023-2025 was published in the Official Gazette on September 5, 2023.
The PNHTA designs a new governance model for medical devices by providing for the creation of an integrated HTA ecosystem at all levels of decision-making in the NHS, national, regional and corporate.
The new National HTA Program 2023-2025 was created to support the creation of a new medical device governance model in the NHS, and is based, for its action to be truly effective and efficient, on two essential principles:
- the use of HTA at all levels of decision-making in our National Health Service in an integrated way, avoiding duplication and initiating a process of system-wide enhancement of the potential benefits of HTA;
- the use of HTA at all moments in the life cycle of a technology, from the time of its development in the different stages of research and development until its introduction on the market and then until the time of its obsolescence.
The scope of PNHTA focuses not only on the technology as such, but on it embedded in a process of care. The entire National HTA Program is designed to create a fully integrated system of technology assessment that, starting at the European level*, while respecting the competencies and attributions of each institutional level, provides real support for health service planning activities.
The priority objective of the PNHTA is to use HTA as a real tool to support decision-making processes both at the macro level in the national and regional spheres, and at the corporate level, in the awareness that only with a true integration of these decision-making levels will it be possible to create a governance system capable of assessing the real needs for medical devices, identifying those that best meet the real health needs and evaluating the real benefits generated by them, thus creating the conditions for better planning and allocation of resources to be allocated to the NHS.
National HTA Medical Devices Program 2023-2025 (OJ General Series No. 207, 05-09-2023) 
PDF
Brochure (PDF)
For more information on the Italian National Health Technology Programme (LINK)
*Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en